The Food and Drug Administration granted emergency use authorization for Abbott Laboratories’ new coronavirus test that detects Covid-19 antibodies….
Abbott said it plans to ship nearly 30 million tests this month and will have the capacity to ship 60 million tests in June. The tests can indicate whether a person has had Covid-19 and was either asymptomatic or recovered.
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The authorization means laboratories will be allowed to use the test even though it has not been formally approved or cleared by the FDA.
U.S. officials and corporations across America are pouring money into antibody testing, hoping it will give people the confidence to return to work and reopen parts of the economy.
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The company announced last month that it was working with CVS Health to get its tests “outside of the hospital” and into places like urgent-care clinics and nursing homes.
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Since the FDA issued its initial antibody test policy in mid-March, the agency said it has become aware of “a concerning number” of commercial serology tests being promoted inappropriately, including for diagnostic use, or performing poorly.
